OsteoarthritisPhase 4NCT02770950
Zushima Plaster for Treating Knee Osteoarthritis
A Phase 4 study testing Zushima plaster with high dose, Zushima plaster with low dose and Indometacin Cataplasms in people with Osteoarthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima plaster for patients in knee osteoarthrosis post-marketing. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Zushima plaster with high dose, Zushima plaster with low dose and Indometacin Cataplasms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 40-75;
- Unilateral or bilateral knee OA, confirmed radiographically;
- Patients taking oral NSAIDs prior to the breakthrough period will be permitted;
- VAS pain score is or above 20mm.
Who cannot join
- Knee is swollen and hot;
- Allergic to any ingredient in Girald Daphne Bark Plaster (Girald Daphne Bark, Lithargite, Linseed oil, Red lead) ;
- Congestive Heart Failure and Edema;
- Advanced renal disease;
- Knee joint skin is burst or skin disease or allergies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zushima Plaster for Patients in Knee Osteoarthritis: a Random, Positive Drug Controlled, Multi-center Clinical Research
The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima plaster for patients in knee osteoarthrosis post-marketing.
- Conditions
- Osteoarthritis
- Being tested
- Zushima plaster with high dose, Zushima plaster with low dose, Indometacin Cataplasms
- Keywords
- Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zushima plaster with high doseDrug
Patients in high dose Zushima plaster group will use Zushima plaster topically on knee(s) for 24h per day.
Zushima plaster with low doseDrug
Patients in low dose Zushima plaster group will use Zushima plaster topically on knee(s) for 12h per day.
Indometacin CataplasmsDrug
Patients in Indometacin Cataplasms group will use Indometacin Cataplasms on knee(s)for 24h per day.
| Study group | Role | What they receive |
|---|---|---|
| High dose group | Active comparator | High dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 24h per day.
Eligible subjects will use a piece of Zushima plaster topically for each knee for 24h per day. Receives: Drug: Zushima plaster with high dose |
| Low dose group | Active comparator | Low dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 12h per day.
Eligible subjects will use a piece of Zushima plaster topically for each knee for 12h per day. Receives: Drug: Zushima plaster with low dose |
| Controlled group | Active comparator | Indometacin Cataplasms will be used topically on the knee for 24h per day Receives: Drug: Indometacin Cataplasms |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment
Measured: Week 2.
Secondary outcomes (6)
the change of Patient's global assessment of disease activity from baseline to posttreatment
Measured: Week 2.
the change of WOMAC Osteoarthritis Index from baseline to posttreatment
Measured: Week 2.
the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment
The SF-36 is a generic instrument to assess health-related quality of life. It consists of 36 questions and assesses 8 dimensions: physical functioning, role physical, pain index, general health, vitality, social functioning, role emotional, and mental health index. It also provides 2 summary measures of physical and mental components. The SF-36 score ranges from 0 to 100, with higher scores indicating better health status.
Measured: Week 2.
the change of Erythrocyte Sedimentation rate (ESR) from baseline to posttreatment
ESR, also called a sedimentation rate, is the rate at which red blood cells sediment in a period of one hour. It is a non-specific measure of inflammation.
Measured: Week 2.
the change of C-reactive protein (CRP) from baseline to posttreatment
Measured: Week 2.
the change of knee musculoskeletal ultrasound (MSUS) from baseline to posttreatment
MSUS had wisely using in rheumatology practice and research. MSUS includes synovitis classification, synovial hyperplasia classification, articular cavity effusion and bone erosion classification. Specific as follows: Synovitis classification: 0 level, no doppler signal; level 1: three independent point or 2 successive or 1 and 2 in independent dot doppler signal; level 2: doppler signal < 50% of the synovial membrane area; level 3 doppler signal is the synovium in > 50% of the area. Synovial hyperplasia classification: 0 level, no synovial hyperplasia; level 1: synovial hyperplasia of mild, not more than bone surface high attachment; level 2: synovial hyperplasia more than bone surface high wire, but not more than the backbone; level 3: synovial hyperplasia more than bone surface peak wires, and extends along the backbone of the side. Articular cavity effusion and bone erosion classification: adopt binary evaluation, namely 0: normal, 1: abnormal.
Measured: Week 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital of Traditional Chinese Medicine, Beijing Hospital, Beijing Jishuitan Hospital, Beijing Shijitan Hospital, Capital Medical University, Shanghai Municipal Hospital of Traditional Chinese Medicine, Gansu Provincial Hospital, General Hospital of Beijing Military Area
- Responsible party
- Principal investigator, Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Quan Jiang, MD. PhD., Principal investigator, Rheumatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770950
- Sponsor's protocol ID
- 81758
- Status last verified
- Nov 2018
- First submitted
- 2 May 2016
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zushima Plaster for Patients in Knee Osteoarthritis: a Random, Positive Drug Controlled, Multi-center Clinical Research
- ClinicalTrials.gov ID
- NCT02770950
- Acronym / sponsor ID
- 81758
- Conditions
- Osteoarthritis
- Keywords
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing Hospital of Traditional Chinese Medicine, Beijing Hospital, Beijing Jishuitan Hospital, Beijing Shijitan Hospital, Capital Medical University, Shanghai Municipal Hospital of Traditional Chinese Medicine, Gansu Provincial Hospital, General Hospital of Beijing Military Area
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima plaster for patients in knee osteoarthrosis post-marketing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose group | Active comparator | Drug: Zushima plaster with high doseHigh dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 24h per day. Eligible subjects will use a piece of Zushima plaster topically for each knee for 24h per day. |
| Low dose group | Active comparator | Drug: Zushima plaster with low doseLow dose of Zushima plaster: a piece of Zushima plaster will be used topically for each knee for 12h per day. Eligible subjects will use a piece of Zushima plaster topically for each knee for 12h per day. |
| Controlled group | Active comparator | Drug: Indometacin CataplasmsIndometacin Cataplasms will be used topically on the knee for 24h per day |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 40-75;
- Unilateral or bilateral knee OA, confirmed radiographically;
- Patients taking oral NSAIDs prior to the breakthrough period will be permitted;
- VAS pain score is or above 20mm.
Key exclusion criteria (5 listed)
- Knee is swollen and hot;
- Allergic to any ingredient in Girald Daphne Bark Plaster (Girald Daphne Bark, Lithargite, Linseed oil, Red lead) ;
- Congestive Heart Failure and Edema;
- Advanced renal disease;
- Knee joint skin is burst or skin disease or allergies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zushima plaster with high dosePatients in high dose Zushima plaster group will use Zushima plaster topically on knee(s) for 24h per day. | Drug | High dose group |
| Zushima plaster with low dosePatients in low dose Zushima plaster group will use Zushima plaster topically on knee(s) for 12h per day. | Drug | Low dose group |
| Indometacin CataplasmsPatients in Indometacin Cataplasms group will use Indometacin Cataplasms on knee(s)for 24h per day. | Drug | Controlled group |
Primary outcome
the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment
Time frame: Week 2.
6 secondary outcomes
the change of Patient's global assessment of disease activity from baseline to posttreatment
Time frame: Week 2.
the change of WOMAC Osteoarthritis Index from baseline to posttreatment
Time frame: Week 2.
the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment
Time frame: Week 2.
the change of Erythrocyte Sedimentation rate (ESR) from baseline to posttreatment
Time frame: Week 2.
the change of C-reactive protein (CRP) from baseline to posttreatment
Time frame: Week 2.
the change of knee musculoskeletal ultrasound (MSUS) from baseline to posttreatment
Time frame: Week 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quan Jiang, MD. PhD. principal investigator
Rheumatology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zushima plaster with high dose, Zushima plaster with low dose and Indometacin Cataplasms in people with Osteoarthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment (time frame: Week 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.